Butoconazole

DEA Class; Rx, OTC

Common Brand Names; Femstat 3, Gynazole 1

  • Antifungals, Vaginal

Imidazole antifungal agent that is fungicidal in vitro against Candida spp.; available as a vaginal preparation; multiple dose products available OTC; single dose product available by prescription only.

Indicated for the treatment of vulvovaginal candidiasis (VVC).

Hypersensitivity to drug

1st trimester of pregnancy

Pelvic/abdominal pain or cramping

Vulvar/vaginal irritation, soreness, and swelling

Hypersensitivity to other azoles

Contains mineral oil, which may weaken latex or rubber products

Consider HIV infection in sexually active women with difficult to eradicate recurrent yeast infection

Pregnancy Category: C

Lactation: not known if excreted in breast milk; use caution

Adults

1 applicatorful (100 mg butoconazole/5 g cream) intravaginally/day.

Geriatric

1 applicatorful (100 mg butoconazole/5 g cream) intravaginally/day.

Adolescents

Safety and efficacy have not been established; however, 1 applicatorful (100 mg butoconazole/5 g cream) intravaginally/day has been used off-label.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Butoconazole nitrate

vaginal cream

  • 2%

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